Skip to Content

Cold and Flu Multi-Symptom Daytime/Nighttime Severe

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: COSTCO WHOLESALE CORPORATION
NDC Code: 63981-702

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Kirkland 44-503A473C

Active ingredients (in each caplet)
(Daytime Cold & Flu Severe)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain  reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Active ingredients (in each caplet)
(Nighttime Cold & Flu Severe)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant

Uses
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • headache
    • sore throat
    • minor aches and pains
    • nasal congestion
    • sinus congestion and pressure (Nighttime only)
    • sneezing and runny nose (Nighttime only)
  • help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (Daytime only)
  • helps clear nasal passages (Nighttime only)
  • relieves cough to help you sleep (Nighttime only)
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • 3 or more alcoholic drinks every day while using this product
  • with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

Ask a doctor before use if you have
  • liver disease
  • diabetes
  • thyroid disease
  • heart disease
  • glaucoma (Nighttime only)
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product
  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • be careful when driving a motor vehicle or operating machinery (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • new symptoms occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding,

 ask a health professional before use.

Keep out of reach of children.‚Äč

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.

Directions
  • do not take more than directed
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • see end flap for expiration date and lot number
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients (Daytime only)

corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Inactive ingredients (Nighttime only)

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

 1-800-426-9391

Principal display panel

KIRKLAND
Signature

COMPARE TO TYLENOL®
COLD + FLU SEVERE DAY
active ingredients* Non-Drowsy

DAYTIME SEVERE
COLD & FLU
MULTI-SYMPTOM

Acetaminophen 325 mg,
Dextromethorphan HBr 10 mg,
Guaifenesin 200 mg, Phenylephrine HCl 5 mg

Pain reliever • Fever Reducer • Cough Suppressant
Expectorant • Nasal Decongestant

Relieves:
Head and Body Aches
Fever and Sore Throat
Nasal Congestion
Cough
Mucus and Chest Congestion

Actual Size

2 x 60
CAPLETS

KIRKLAND
Signature

COMPARE TO TYLENOL®
COLD + FLU SEVERE NIGHT
active ingredients*

NIGHTTIME SEVERE
COLD & FLU
MULTI-SYMPTOM

Acetaminophen 325 mg,
Chlorpheniramine Maleate 2 mg,
Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

Pain reliever • Fever Reducer • Antihistamine
Cough Suppressant • Nasal Decongestant

Relieves:
Head and Body Aches
Fever and Sore Throat
Nasal Congestion
Cough
Runny Nose

Actual Size

48
CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® COLD + FLU  SEVERE Day & Tylenol® COLD + FLU SEVERE Night.

50844 ORG031650347381

This product does not contain gluten.

Manufactured by:
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA

For: Costco Wholesale Corporation
P.O. Box 34535
Seattle, WA 98124-1535 USA
1-800-774-2678
www.costco.com
16V1012a

Kirkland 44-503A473C

COLD AND FLU MULTI-SYMPTOM  DAYTIME/NIGHTTIME SEVERE
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, guaifenesin and phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-702
Packaging
#Item CodePackage Description
1NDC:63981-702-811 KIT in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 110 BLISTER PACK 120 
Part 24 BLISTER PACK 48 
Part 1 of 2
COLD AND FLU MULTI-SYMPTOM  DAYTIME SEVERE
acetaminophen, dextromethorphan hbr, guaifenesin and phenylephrine hcl tablet, film coated
Product Information
Item Code (Source)NDC:63981-503
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSPOVIDONE 
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
STEARIC ACID 
SILICON DIOXIDE 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
POLYVINYL ALCOHOL, UNSPECIFIED 
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize19mm
FlavorImprint Code44;503
Contains    
Packaging
#Item CodePackage Description
1NDC:63981-503-115 BLISTER PACK in 1 BOX
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/04/2005
Part 2 of 2
COLD AND FLU MULTI-SYMPTOM  NIGHTTIME SEVERE
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hcl tablet, film coated
Product Information
Item Code (Source)NDC:63981-473
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSPOVIDONE 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
POLYVINYL ALCOHOL, UNSPECIFIED 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize17mm
FlavorImprint Code44;473
Contains    
Packaging
#Item CodePackage Description
1NDC:63981-473-224 BLISTER PACK in 1 BOX
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/21/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/04/2005
Labeler - COSTCO WHOLESALE CORPORATION (103391843)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(63981-702, 63981-503, 63981-473)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(63981-702, 63981-503, 63981-473)

 
COSTCO WHOLESALE CORPORATION

Medically reviewed on Jul 27, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide